The RISE FOR HEALTH study: Methods for in-person assessment and biospecimen collection

The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: To describe the methods for the in-person assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors that promote bladder health and/or prevent lower urinary tract symptoms in adult women, conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). Methods and results: A subset of RISE participants who express interest in the in-person assessment will be screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete 15 physical assessments in addition to height and weight, to assess pelvic floor muscle function, musculoskeletal (MSK) status, and pain, and to provide urogenital microbiome samples. Pelvic floor muscle assessments include presence of prolapse, strength, levator attachment integrity (tear) and myofascial pain. MSK tests evaluate core stability, lumbar spine, pelvic girdle and hip pain and function. Participants are asked to complete the Short Physical Performance Battery to measure balance, lower extremity strength, and functional capacity. All participants are asked to provide a voided urine sample and a vaginal swab for microbiome analyses; a subset of 100 are asked to contribute additional samples for feasibility and validation of a home collection of urinary, vaginal, and fecal biospecimens. Results: Online and in-person training sessions were used to certify research staff at each clinical center before the start of RISE in-person assessments. Standardized protocols and data collection methods are employed uniformly across sites. Conclusions: The RISE in-person assessment is an integral portion of the overall population-based RISE study and represents an innovative approach to assessing factors hypothesized to promote bladder health and/or prevent lower urinary tract symptoms. Data collected from this assessment will be used to prioritize future research questions and prevention strategies and interventions. This description of the assessment methods is intended to provide methodologic transparency and inform other researchers who join efforts to understand and improve bladder health.

Original languageEnglish (US)
JournalNeurourology and Urodynamics
DOIs
StateAccepted/In press - 2022

Bibliographical note

Funding Information:
We gratefully acknowledge the collegial research work of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium members. Loyola University Chicago—Maywood, IL (U01DK106898). Multi‐Principal Investigators: Linda Brubaker, MD; Elizabeth R. Mueller, MD, MSME. Investigators: Marian Acevedo‐Alvarez, MD; Colleen M. Fitzgerald, MD, MS; Cecilia T. Hardacker, MSN, RN, CNL; Jeni Hebert‐Beirne, PhD, MPH; Missy Lavender, MBA. Northwestern University—Chicago IL (U01DK126045). Multi‐Principal Investigators: James W. Griffith, PhD; Kimberly Sue Kenton, MD; Melissa Simon, MD, MPH; Investigator: Julia Geynisman‐Tan, MD; University of Alabama at Birmingham—Birmingham, AL (U01DK106858). Principal Investigator: Alayne D. Markland, DO, MSc. Investigators: Tamera Coyne‐Beasley, MD, MPH, FAAP, FSAHM; Kathryn L. Burgio, PhD; Cora E. Lewis, MD, MSPH; Gerald McGwin, Jr., MS, PhD; Camille P. Vaughan, MD, MS; Beverly Rosa Williams, PhD. University of California San Diego—La Jolla, CA (U01DK106827). Principal Investigator: Emily S. Lukacz, MD. Investigators: Sheila Gahagan, MD, MPH; D. Yvette LaCoursiere, MD, MPH; Jesse Nodora, DrPH. University of Michigan—Ann Arbor, MI (U01DK106893). Principal Investigator: Janis M. Miller, PhD, APRN, FAAN. Investigators: Lisa Kane Low, PhD, CNM, FACNM, FAAN. University of Minnesota (Scientific and Data Coordinating Center)—Minneapolis MN (U24DK106786). Multi‐Principal Investigators: Bernard L. Harlow, PhD; Kyle D. Rudser, PhD. Investigators: Sonya S. Brady, PhD; Haitao Chu, MD, PhD; Cynthia S. Fok, MD, MPH; Peter Scal, PhD; Todd Rockwood, PhD. University of Pennsylvania—Philadelphia, PA (U01DK106892). Principal Investigator: Multi‐Principal Investigators: Diane K. Newman, DNP FAAN; Ariana L. Smith, MD. Investigators: Amanda Berry, MSN, CRNP; Heather Klusaritz, PhD, MSW; Ann E. Stapleton, MD; Jean F. Wyman, PhD. Washington University in St. Louis—Saint Louis, MO (U01DK106853). Principal Investigator: Siobhan Sutcliffe, PhD, ScM, MHS. Investigators: Aimee S. James, PhD, MPH; Jerry L. Lowder, MD, MSc; Melanie R. Meister, MD, MSCI. Yale University—New Haven, CT (U01DK106908). Principal Investigator: Leslie M. Rickey, MD, MPH. Investigators: Marie A. Brault, PhD; Deepa R. Camenga, MD, MHS; Shayna D. Cunningham, PhD. Steering Committee Chair: Linda Brubaker, MD. UCSD, San Diego. (January 2021‐). NIH Program Office: National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic, and Hematologic Diseases, Bethesda, MD. NIH Project Scientist: Julia Barthold, M.D. This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) by cooperative agreements (U24 DK106786, U01 DK106853, U01 DK126045, U01 DK106858, U01 DK106898, U01 DK106893, U01 DK106827, U01 DK106908, U01 DK106892). The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additional funding from: National Institute on Aging, NIH Office of Research on Women's Health.

Publisher Copyright:
© 2022 Wiley Periodicals LLC.

Keywords

  • bladder
  • microbiome
  • musculoskeletal assessment
  • pelvic floor
  • women

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